Abstract: An improved balloon catheter structure includes a beveled distal tip, a reinforced distal portion, and an elastic or split sleeve over at least a portion of the balloon. The balloon may have a short length and a marker at its midline. The catheters are particularly useful for crossing through stent walls at vessel bifurcations.

Abstract: A medical device is provided comprising a catheter, a balloon mounted on the catheter, and a sheath comprising a shape memory material, the sheath being located around the balloon. The sheath has a protective condition in which the sheath forms a plurality of pockets in a generally closed position and an activated condition in which the pockets are in a generally open position. A therapeutic agent is located within the generally closed pockets of the sheath when the sheath is in the protective condition. The therapeutic agent is exposed for delivery to a target site when the sheath is transitioned from the protective condition to the activated condition.

Abstract: Methods and apparatus for a free-standing biodegradable patch suitable for medical applications, especially intravascular, minimally-invasive and intraoperative surgical applications are provided, wherein the patch comprises a free-standing film or device having a mixture of a solid fibrinogen component and a solid thrombin component that, when exposed to an aqueous environment, undergoes polymerization to form fibrin. In alternative embodiments the patch may comprise a solid fibrinogen component, with or without an inorganic calcium salt component. The patch may take a non-adherent form during delivery to a target location within a vessel or tissue, and thereafter may be activated to adhere to vessel wall or tissue, and may include a number of additives, including materials to improve the mechanical properties of the patch, or one or more therapeutic or contrast agents.

Abstract: Methods and apparatus for a free-standing biodegradable patch suitable for medical applications, especially intravascular, minimally-invasive and intraoperative surgical applications are provided, wherein the patch comprises a free-standing film or device having a mixture of a solid fibrinogen component and a solid thrombin component that, when exposed to an aqueous environment, undergoes polymerization to form fibrin. In alternative embodiments the patch may comprise a solid fibrinogen component, with or without an inorganic calcium salt component. The patch may take a non-adherent form during delivery to a target location within a vessel or tissue, and thereafter may be activated to adhere to vessel wall or tissue, and may include a number of additives, including materials to improve the mechanical properties of the patch, or one or more therapeutic or contrast agents.

Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The distal end of the sheath is maintained in the first, low cross-sectional configuration and expanded using a radial dilatation device. In an exemplary application, the sheath is utilized to provide access for a diagnostic or therapeutic procedure such as ureteroscopy or stone removal.

Abstract: A balloon elongation apparatus includes an elongated hypotube with a distal end having a reduced inner diameter portion that is configured to radially expand when a mandrel is advanced through a lumen of the hypotube towards the reduced inner diameter portion. A medical kit includes a catheter having a distally-located balloon and the elongation apparatus disposed within a guide wire tube of the catheter. In use, the balloon is elongated following a procedure in order to facilitate retracting the balloon into a sheath. The balloon is elongated by first advancing the mandrel relative to the hypotube so that the hypotube radially expands and firmly engages an inner surface of the guide wire tube and then advancing the mandrel, hypotube, and distal end of the guide wire tube relative to the catheter body.

Abstract: A thin-walled sheath is placed over a balloon having an antirestenotic drug placed on the balloon of a balloon dilatation catheter. The sheath protects the drug from dissolution into the blood and allows improved delivery to the lesion site. A rolling action of the sheath prevents the drug from loss due to shearing motion. The sheath can also provide a protected surface for carrying the drug and providing exposure to the lesion site for delivery of the drug. The sheath can also serve as a delivery sheath for providing delivery of a stent via a single catheter introduction for drug delivery and stent delivery.

Abstract: A stent comprises at least one stent member woven to form a substantially tubular body that defines a flow path. The tubular body comprises a first region and a second region. In the first region the at least one stent member defines a plurality of first region openings and in the second region at least one first portion of the at least one member and at least one second portion of the at least one member are engaged together to form at least one primary strand. The at least one primary strand defines a plurality of second region openings. The at least one of the plurality of second region openings is in fluid communication with the flow path. The plurality of second region openings provide the second region with a greater porosity than the first region.

Abstract: A catheter assembly may comprise a guide catheter, a balloon catheter with a steering balloon and a stabilizing balloon and a guide wire. The stabilizing balloon secures the balloon catheter to the guide catheter while the steering balloon secures the catheter assembly to the vessel wall. In another embodiment, the balloon catheter has three balloons engaged to the exterior surface, a steering balloon, a stabilizing balloon and an anchoring balloon.

Abstract: A medical device is provided that may include a catheter body having proximal and distal portions, a fluid injection lumen disposed within elongate body, and a guidewire lumen disposed within the elongate body. A tip portion defining a cavity in fluid communication with the fluid injection lumen may be coupled to the distal end of the guidewire lumen, and an expandable element may be coupled to the distal portion of the catheter body and to the tip portion, such that the expandable element is in fluid communication with the fluid injection lumen. A shaping element may at least partially surround the expandable element, where the shaping element is configurable in a first geometric configuration and a second geometric configuration.

Abstract: A method for percutaneously implanting a medical catheter, such as a gastrostomy feeding tube, and a medical catheter implanting assembly. In one embodiment, the implanting assembly includes a gastrostomy feeding tube, an inner sheath and an outer sheath. The feeding tube has an internal bolster integrally formed at its distal end. The inner sheath includes a bore extending distally from its proximal end to a point prior to its distal end and a transverse window communicating with the bore. The outer sheath includes a proximal end, a distal end and a longitudinal bore. The outer sheath is inserted over the inner sheath, and the feeding tube is inserted into the inner sheath, with the internal bolster being folded and tucked into the window and retained therein by the outer sheath. Movement of the outer sheath relative to the inner sheath to expose the window allows the bolster to decompress.

Abstract: A system is disclosed for cannulating the vena cava of a patient during cardiopulmonary bypass procedures. Such cannulation is necessary for drainage of venous blood from the patient so that it may be oxygenated and pumped back to the patient to perfuse tissues during cardiac surgery and, more specifically, during periods of ischemic cardiac arrest or dysfunction. The device of the present invention not only provides venous drainage for cardiopulmonary bypass, but also performs the function of routing cardioplegic solution through the heart in the retrograde direction. Such cardioplegia provides protection to the heart during periods of ischemic cardiac arrest. This invention replaces a plurality of cannulae currently used for open-heart surgery, thus simplifying the surgical field and improving visibility of the heart. The device allows for the delivery of retrograde cardioplegia to the coronary circulation of both the right and the left side of the heart.

Abstract: A balloon catheter is provided having an expandable distal portion and balloon protector means comprising a first removable sleeve having a variable inner diameter to ease sliding the first sleeve over the balloon, and an optional second removable (outer) sleeve positioned over the inner sleeve, the second (outer) sleeve having a constrictive relationship with the first (inner) sleeve, said first and second sleeves being removed prior to use of the catheter.

Abstract: A first balloon is fitted to an insertion portion of an endoscope and a second balloon is fitted to an insertion aid member. An end connector of a tube is connected to a balloon control device that supplies and sucks air into and from the first balloon and the second balloon. A duct that communicates with the first balloon, a duct that communicates with the second balloon, and a duct that communicates with a clearance between the insertion portion and the insertion aid member are formed in the end connector.

Abstract: An expandable medical balloon including an inner layer formed of a poly(ether-block-amide) copolymer and an outer layer formed of a polyamide, the expandable medical balloon having a burst strength of greater than 50,000 psi, and to methods of making and using the same.

Abstract: A translumenal access device may comprise a catheter, an inflatable member, a hollow needle, a stylet, and a guide wire. The catheter may comprise at least one first lumen and at least one second lumen. The at least one first lumen may be configured to slidably receive the guide wire from the proximal end to the distal end of the catheter. The inflatable member may be mounted near the distal end of the catheter, and may be in fluid communication with second lumen. The hollow needle may be mounted on the distal end of the catheter. The hollow needle may be mounted distal to the inflatable member. The stylet may comprise a third lumen and may be configured to be slidably disposed within the hollow needle. The sylet has at least one extended position and at least one retracted position.

Abstract: An indwelling urinary catheter assembly is disclosed having an indwelling catheter and a sheath enclosing an insertable portion of the indwelling catheter.

Abstract: A sensor element, a sensor system, a catheter that can detect the thrombi, plaques and stents in the blood vessels and manufacturing method of the sensor element are provided. A cylinder is formed as a cylinder shaped part that has a long inner space and one open end. The cylinder has a slit being formed along an axis and the width of the slit is less than diameter of the inner space. A plurality of coils is wound outside of the cylinder and the lead portions of the coils are led into the inner space of the cylinder by passing through the slits. Electrically conducting means are connected to each of lead portions and are externally led out from the open end of the cylinder.

Abstract: A catheter enabling an increase in operability when the catheter is inserted from the outside to the inside of a body and capable of remarkably reducing the risk of damage to shafts even in an unforeseen accident without complicating steps and increasing production cost. The catheter comprises at least the distal side shaft formed of a resin tube, the rear end side shaft with a higher rigidity than that of the distal side shaft, and a guide wire lumen. The catheter is characterized in that a core wire is disposed therein to adjust a flexibility so that the rear end portion of the distal side shaft is harder than the distal end portion of the distal side shaft and softer than the rear end side shaft, and the core wire is fixed to the distal side shaft near the rear end side opening part of the guide wire lumen and at a part of the rear end side portion of the distal end shaft.

Abstract: A catheter for use in a medical procedure includes an elongate outer member, an elongate inner member and an expandable distal tip attached to a distal most end of at least one of the outer member or inner member, wherein the distal tip has a first shape and a second shape and the tip can be easily transformed between the first and second shapes to aid in navigation through a patient's vascular system. A method of using the catheter includes inserting the catheter into the vascular system, navigating the distal end of the catheter through the vascular system, determining an obstruction within the vascular system, modifying the expandable tip from the first shape to the second shape in response to the determination of the obstruction, advancing the modified expandable tip passed the determined obstruction and returning the modified expandable tip to the first shape upon passing the determined obstruction.

Abstract: Catheter devices having an expandable balloon for delivering a therapeutic agent to a body site. In one aspect, one or more sheaths are disposed around the balloon with the therapeutic agent being disposed within the sheath, being disposed over the sheath, being contained in the space between the sheath and the balloon, or being otherwise associated with the sheath. In another aspect, the balloon includes a micro-electromechanical system (MEMS) for drug delivery.

Abstract: An feeding tube and a kit for installation of a feeding tube includes a balloon anchored gastric tube. A protective sleeve on a dilator protects the toroidal balloon from damage during surgical insertion of the feeding tube. In one example, a jejunal tube is integrated with the kit and the gastric tube serves as a gastric sleeve forming an annular region or channels for fluid flow to and/or from the stomach and to/from the jejunum. An integrated gastro jejunal feeding tube unit may include a jejunal tube outlet port at one end, a jejunal balloon port, a gastric sleeve outlet port, one or more gastric balloon ports, one or more gastric balloons, gastric drainage holes, a jejunal balloon positioned at end of the jejunal tube and sleeve. A black silk loop may affix an end of the jejunal tube at a position in the jejunum, and insertion of the jejunal tube may be monitored continuously using an endoscope. Drainage holes may be provided in the jejunal tube and/or the gastric sleeve.

Abstract: A delivery system for delivering a self-expanding medical device such as a stent. The delivery system includes a sheath profiled or shaped to reduce instances of interference between a distal edge of the sheath and a vessel or with any lesion or lesions that might be present in the vessel. The sheath is formed by modifying a cylinder of sheath material to include three portions and an initiation slit that controls the rupturing of the sheath to facilitate delivery of the medical device. The initiation slit is positioned on the delivery system with respect to a configuration of a balloon portion of the system.

Abstract: The present invention involves an expandable element with an outer sticky surface. The expandable element may be in the form of a balloon with deflated and inflated configurations. The expandable element serves to both dilate a lumen in a blood vessel thereby opening it and to exert force upon the sticky surface in order to press it into apposition against a vessel wall. The outer sticky surface may be provided directly upon the expandable element or on a separate outer sheath that conforms to and follows the contours of the expandable element. The sticky surface may take the form of a biochemical composition and/or a mechanically abrasive structure such as microhooks, hairs, mesh netting, etc. Optionally, additional expandable elements may be provided proximal and distal to the main element to occlude blood flow on either side of a lesion in order to better trap emboli for collection.

Abstract: The invention relates to a cover (1) for a medical instrument (3), which is characterized in that the cover (1) is a generally pipe-shaped body and consists of one single tape (11) which extends generally helicoidally about the axis of the pipe-shaped body. The invention furthermore relates to a process for applying a cover (1) onto a medical instrument (3) as well as to a medical instrument (3) which is provided with a cover (1).

Abstract: A trocar assembly including a trocar and a trocar sheath and methods for accessing an intracorporeal site, e.g. biopsy or trocar site, using the trocar assembly. The trocar has a tissue penetrating distal tip, an elongated shaft and a proximal handle portion. The distal portion of the trocar sheath forms a releasable connection, such as a friction fit, with the shaft of the trocar and a slit that extends from the distal portion to the proximal end of the trocar sheath. The trocar assembly is advanced through the patient's tissue until the distal end of the trocar sheath is located at the desired site and then the trocar is removed. A treatment device such as a radiation balloon catheter is advanced through the interior of the sheath until the treatment component thereof is at the desired site.

Abstract: Systems and methods for measuring the pressure exerted between or within anatomical masses/structures, as well as the position and/or spatial dimensions of an anatomical structure. According to a preferred embodiment, the invention comprises a sensor element positionable between anatomical structures or within an anatomical structure. The sensor is operative to generate a signal indicative of the pressure being exerted therebetween or therewithin. The sensor may be operative to measure spatial dimensions between structures or within a structure. A monitor coupled to the sensor receives a signal generated thereby and provides an indication as to the spacing or pressure being measured. The systems and methods may be utilized in diagnostic tests or surgical procedures.

Abstract: An apparatus and method for automatically retroperfusing a coronary vein. The apparatus includes an intraluminal graft having a tubular body extending between a proximal end and a distal end. The proximal end is for fluidly connecting to an artery to automatically supply retrograde blood for retroperfusion. The tubular body and the distal end are extendable into a vein that is fluidly connected with the coronary vein to be retroperfused. The distal end includes an expandable stent for securing the distal end in the coronary vein.

Abstract: A medical device delivery system includes a self-expanding medical device mounted on a balloon portion of a catheter. A sheath is provided around the medical device to hold the device in place with the device staying in a compressed state. A series of perforations or an initial cut is provided in the sheath at a predetermined location, or within a predetermined range of locations, on the circumference of the sheath. The predetermined location or range of locations are determined with respect to the folds of the balloon portion.

Abstract: Methods and apparatus for the treatment of venous insufficiency, such as varicose veins, are described herein utilizing endovenous treatments. Such treatments may include systems to create an initial endovascular injury to the vessel wall utilizing any number of mechanisms, such as chemical, mechanical, electrical, etc. modalities. An implantable device, optionally having a sclerosing agent infused therein, may additionally be implanted along the injured tissue to promote, maintain, and otherwise enhance the tissue inflammation and scarring, thereby remodeling the diseased vessel wall.

Abstract: Apparatus for treatment of a vascular bifurcation, where a first blood vessel (24) meets a second blood vessel (26). The apparatus includes a balloon (40, 90) for deployment at the vascular bifurcation. The balloon includes a first part (42, 94), which has a first inflation characteristic and is adapted to be deployed in the first blood vessel, and a second part (44, 92), which has a second inflation characteristic, different from the first inflation characteristic, and is adapted to be deployed in the second blood vessel.

Abstract: A method of using a balloon catheter to perform a medical procedure at a treatment site in a patient's body lumen and to recover an expanded device, such as an embolic protection device, which is adjacent to the treatment site in the body lumen. The inflated balloon is deflated and regroomed to a low profile configuration in the body lumen, and the balloon catheter is advanced distally from the treatment site to collapse the expanded device (e.g., embolic protection filter) within the balloon catheter. The balloon catheter has a recovery distal tip for collapsing an expanded device, and has a regrooming sheath member configured to slidably receive the deflated balloon therein to regroom the balloon.

Abstract: A balloon catheter having a pre-mounted recovery sheath for recovering an expanded device, such as an embolic protection device, in a patient's body lumen, and a method of using a balloon catheter system of the invention to recover the expanded device

Abstract: Tis invention is new apparatuses and methods for treatments to be used from inside conduits or biological pathways. Examples of the biological pathways in which these new apparatuses and methods may be used include arteries, veins, and respiratory ways. Multi-purpose catheters (10) and catheter systems using structures including wires (2108), balloons (2150), and cords (2204) are described as well as methods to use such catheters and catheter systems. One of the embodiments is a configurable wire system which carries or transports radioactive sources. The wire is used in conjunction with a closed-end channel catheter.

Abstract: Embodiments of the present disclosure provide a delivery apparatus for delivering a prosthetic heart valve to a native valve site via the human vasculature. The delivery apparatus is particularly well-suited for advancing a prosthetic valve through the aorta (i.e., in a retrograde approach) for replacing a stenotic aortic valve.

Abstract: A stent delivery assembly comprises a balloon catheter with a rotatable assembly disposed thereabout. The rotatable assembly comprises a rotatable sheath which in a reduced state is freely rotatable about the medical balloon and when in the expanded state is frictionally engaged by the expanded balloon. A secondary guide wire housing is at least partially engaged to the rotatable sheath. A stent may be disposed about at least a portion of the rotatable sheath and at least a portion of the secondary guide wire housing so that a distal end portion of the secondary guide wire housing exits the flow path of the stent through one of the plurality of cell openings which the stent defines.

Abstract: An intravascular device having an elongate shaft and a proximal hub assembly. The proximal hub assembly includes an interference fit member (IFM) which forms an interference fit with a carrier tube to reduce the tendency of the device to fall out of the carrier tube during handling and to provide for easy removal of the device when ready for use.

Abstract: The present invention is directed to an apparatus and method for delivering a drug to a selected site in the vascular system of a patient. More specifically, the apparatus is a balloon catheter comprising an expandable balloon with a pouch around at least a portion of the balloon. When the balloon is not expanded, an agent can be located in the area between the pouch and the balloon. The agent is released through the pouch when the balloon is expanded.

Abstract: A catheter assembly includes a catheter body that extends from a distal end to a proximal end. The catheter body includes a delivery lumen, and an actuator lumen, where the actuator lumen extends from a position near or at the distal end to an intermediate portion that does not extend through the proximal end of the catheter body. The catheter body optionally includes an accessory lumen that extends from at or near the distal end and terminates at an intermediate portion that does not extend through the proximal end surface of the catheter body, for example, on a side wall.

Abstract: The present invention embodies delivery systems and methods for delivering modular endovascular graft devices that allow one portion of the repair device to be deployed while maintaining control of the other portions. The delivery systems are simpler to use, easier to manufacture and facilitate better packing of the repair device.

Abstract: A catheter includes a distal end, a proximal end, an outer tube extending from the distal end to the proximal end, and an inner tube extending through the outer tube. The distal end including a corrugated section attached to an end of the inner tube and an asymmetric balloon attached to the outer tube and configured to deflect the distal end of the catheter.

Abstract: A catheter balloon formed of a polymeric material such as expanded polytetrafluoroethylene (ePTFE) bonded to a second layer formed of a low tensile set polymer and/or impregnated with a low tensile set polymer. In a presently preferred embodiment, the low tensile set polymer is a silicone-polyurethane copolymer elastomer or a diene polymer elastomer. The low tensile set polymer has high strength, low modulus, high elongation, and low tensile set. The diene or silicone-polyurethane has a low tensile set, which facilitates deflation of the balloon to a low profile deflated configuration. One aspect of the invention provides improved attachment of the diene to the ePTFE. In one embodiment, the second layer is formed of a diene mixed with a bonding promoter such as a vulcanizing agent which is covalently bonded to the diene.

Abstract: A balloon catheter and a method of making the balloon catheter, having a balloon which is bonded to an elongated shaft, and which has a first layer and a second layer and an improved strong bond between the balloon and the shaft. One aspect of the invention is directed to a balloon in which the balloon first layer has at least a section with a gas plasma-etched or chemical solution-etched surface for improved bondability. Another aspect of the invention is directed to a balloon in which the balloon first layer has a proximal end section bonded to an outer surface of the shaft and the balloon second layer has a proximal end section bonded to an inner surface of the shaft, and, in one embodiment, at least a section of the balloon first layer has a gas plasma-etched or chemical solution-etched surface.

Abstract: Balloon catheters having the strength and maximum inflated diameter characteristics of an angioplasty balloon and having the recovery characteristics during deflation of an elastic embolectomy balloon. The balloon catheter can be made in very small sizes and has a lubricious and chemically inert outer surface. The balloon catheter is easy to navigate through tortuous passageways, is capable of rapid inflation and deflation and has high burst strengths. Balloon covers having these same characteristics are also described for use with conventional embolectomy balloons or angioplasty balloons.

Abstract: A stent delivery system with an adjustable length balloon. The system includes a stent delivery catheter having an expandable member with an inflated length that can be adjusted according to the length of a stent to be expanded. An exterior sheath having an expandable distal tip is disposed about the expandable member such that the sheath can be longitudinally adjusted so as to expose a desired length of the expandable member. The exposed length of the expandable member provides an effective working length required to expand the stent for deployment. Additionally, where subsequent expansions of the deployed stent may be necessary, post dilitation may be achieved by re-positioning the catheter and re-adjusting the sheath to form an effective working length of the expandable member which corresponds to the length of the stent that needs further expansion.

Abstract: The present invention provides balloon dissection apparatus and methods of use in which an elongate balloon is utilized to dissect along a region that follows a naturally existing path alongside a vessel or structure, such as au artery, a vein, a lymphatic vessel, the trachea, the esophagus, or even a nerve bundle.

Abstract: The present invention provides an assembly and method for topically applying a local anesthetic agent into the trachea and/or hypopharynx during intubation with a tracheal tube. The present invention is designed to topically anesthetize the tracheal surfaces that are in contact with the tracheal tube, thereby preventing the patient from experiencing physiological reactions such as coughing, pain or discomfort from the indwelling tracheal tube, as well as post operative or post extubation laryngospasm. Local anesthetic application can be performed by bolus or continuous infusion.

Abstract: A protector sleeve is disclosed for protecting an expandable member disposed on a catheter during pre-deployment handling. In one embodiment, the protector sleeve includes a tubular member with proximal and distal portions and preferably an elastomer seal therebetween, wherein the proximal portion of the tubular member is designed to slidably engage the expandable member in its collapsed state, while the distal portion permits fluid access to a catheter lumen, e.g., a guidewire lumen, without exposing the protected expandable member to the fluid.

Abstract: A combination dilatation and drug delivery device includes a flexible catheter, a drug delivery sheath mounted to a distal end region of the catheter and a dilatation balloon also mounted to the catheter and contained within a compartment formed by the sheath. The sheath is radially expandable by supplying a liquid therapeutic agent to the compartment under a moderate pressure. The dilatation balloon is expandable by providing a dilatation fluid to the balloon under a much higher pressure. The sheath can be formed of a highly elastic material or can be made quite thin, and in either case is mounted independently of the dilatation balloon. Thus when radially expanded, the sheath is moved into a conforming contact with surrounding vascular tissue. The conforming contact protects tissue and the therapeutic agent from exposure to blood, and more effectively confines the therapeutic agent to the intended treatment area.

Abstract: A dilatation catheter assembly which has a dilatation catheter with a sheath mounted on the catheter shaft having an inner lumen extending in the distal portion of the sheath which is configured to slidably receive at least a portion of the dilatation balloon on the distal end of the catheter. The position of the sheath is fixed with respect to the catheter, e.g. a friction fit or bonded in some manner, before the assembly is inserted into the patient's vasculature with the distal portion of the sheath covering a portion of the balloon but leaving a portion of the balloon uncovered with a length equal to the stenotic region to be dilated so that the entire stenosis can be dilated at the same time. The distal portion of the sheath is preferably formed of a flexible polymeric tube with inelastic reinforcement to prevent substantial expansion thereof when the balloon is inflated.